Home Operations Utilizing Stimulation

NCT04484285 | Completed Results FDA Device

• 1 other identifier: IRB201901518 -A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This project will utilize a home-operated stimulator in 1) a healthy young adult population and 2) a healthy older adult population to provide a proof of concept of home-use of transcutaneous vagal nerve stimulation (tVNS). tVNS is believed to modulate cognitive performance.

Conditions

Cognitive Performance

Outcome Measures

Primary Outcomes (1)

• System Usability Scale

  This is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree). The score range is 10-50 where 50 demonstrates the highest acceptance of the usability of the device and 10 demonstrates the lowest acceptance of the usability of the device.

  Day 7 reported

Study Arms (2)

Younger Cohort

ACTIVE COMPARATOR

Healthy individuals aged 18 - 55

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

Older Cohort

ACTIVE COMPARATOR

Healthy individuals aged 56 - 85

Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

Interventions

Transcutaneous Vagal Nerve Stimulation (tVNS) DEVICE

vagal nerve stimulation

Older Cohort; Younger Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants for one cohort will be adults between the ages of 18-55, consistent with the typical college population
• Participants for the other cohort will be adults between the ages of 56 - 85. Participants must read and write English.

You may not qualify if:

• Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) will be excluded. Participants with any history of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices will be excluded.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida McKnight Brain Institute

Gainesville, Florida, 32643, United States

Location

Limitations and Caveats

The study enrolled only participant into the older adult group. This participant was unable to use the stimulator. To understand the feasibility of this intervention in this group many more older adult participants would need to be enrolled.

Results Point of Contact

• Title: Eric Porges, Associate Profressor
• Organization: University of Florida

eporges@ufl.edu

(352) 294-5838

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: August 20, 2020
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: April 20, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-04

Locations

US (1)